SUPPLY CHAIN ARTICLES

  • Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned

    One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain. 

  • The RNA Therapeutics Supply Chain: A Platform of Relationships

    Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.

  • Defining The RNA Therapeutics Industry In 2023

    Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

  • A "Hot Take" on Personalized mRNA Medicines

    mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.

  • Can America's Retreat On mRNA Be Europe's Opportunity?

    With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.

  • 4 Risk Mitigation Strategies For mRNA Production

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

SUPPLY CHAIN VIDEOS

What challenges do you consider the most formidable in your own mRNA therapeutic development environments?

This Advancing RNA Live clip dives into the biggest challenges in mRNA purification and the critical debate on where to focus investment. Here, our three mRNA PD experts argue for a holistic process development strategy, challenging the traditional wisdom of optimizing the upstream process at any cost.

Can we actually achieve metric-ton siRNA production using enzymatic ligation? While the ligation step is highly scalable, upstream "blockmer" synthesis remains the primary bottleneck. Advancing RNA Live panelists Claire MacCleod and Jill Caswell discuss the shift from "scaling out" to "scaling up" and lessons learned in the process of achieving larger-scale production. 

When asked which specific topic they’d like to see discussed more regularly in the future as it relates to our supply chains, Featured speakers for the "Got Raw Materials? The State Of The mRNA Supply Chain" event were aligned around this one absolutely critical topic...

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